NCT03608839: EDRMT

Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial

Completed Phase 2 Results posted Last updated 8 October 2019

What this trial tests

Phase 2 trial testing Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml in Diabetic Macular Edema in 27 participants. Completed in 5 October 2018.

Timeline

1 May 2016

Primary endpoint
20 December 2017

5 October 2018

Quick facts

Lead sponsor	Universidade Federal de Pernambuco
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	27
Start date	1 May 2016
Primary completion	20 December 2017
Estimated completion	5 October 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml — full drug profile →
• Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml — full drug profile →
• Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml — full drug profile →

Conditions studied

• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

Universidade Federal de Pernambuco — full company profile →

Who can join

Adults 18 to 90, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Macular Thickness at 3 Days After Intravitreous Dexamethasone Primary · Three days after intravitreous dexamethasone

Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm

Group	Value	95% CI
0,01ml Dexamethasone Solution	438.44	± 124.55
0,03 ml Dexamethasone Solution	465.22	± 115.25
0,05 ml Dexamethasone Solution	368.22	± 126.92

Macular Thickness at 28 Days After Intravitreous Dexamethasone Secondary · 28 days after intravitreous dexamethasone

Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm

Group	Value	95% CI
0,01ml Dexamethasone Solution	554.66	± 175.91
0,03 ml Dexamethasone Solution	617.22	± 245.83
0,05 ml Dexamethasone Solution	451.44	± 154.48

Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone Secondary · Three days after intravitreous dexamethasone

Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart

Group	Value	95% CI
0,01ml Dexamethasone Solution	54.22	± 12.77
0,03 ml Dexamethasone Solution	52.33	± 16.09
0,05 ml Dexamethasone Solution	60.22	± 17.28

Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone Secondary · 28 days after intravitreous dexamethasone

Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart

Group	Value	95% CI
0,01ml Dexamethasone Solution	58.33	± 15.46
0,03 ml Dexamethasone Solution	50.55	± 18.51
0,05 ml Dexamethasone Solution	64.11	± 16.01

Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone Secondary · 3 days after intravitreous dexamethasone

Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg

Group	Value	95% CI
0,01ml Dexamethasone Solution	12.33	± 3.90
0,03 ml Dexamethasone Solution	13.11	± 2.42
0,05 ml Dexamethasone Solution	12.44	± 3.97

Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone Secondary · 28 days after intravitreous dexamethasone

Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg

Group	Value	95% CI
0,01ml Dexamethasone Solution	12.33	± 3.16
0,03 ml Dexamethasone Solution	12.44	± 2.74
0,05 ml Dexamethasone Solution	11.88	± 2.80

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected during the study period - 28 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

0,01ml Dexamethasone Solution

Serious: 0/9 (0%)

Deaths: 0

0,03 ml Dexamethasone Solution

Serious: 0/9 (0%)

Deaths: 0

0,05 ml Dexamethasone Solution

Serious: 0/9 (0%)

Deaths: 0

Serious adverse events (2 terms)

Reaction	System	0,01ml Dexamethasone Solut…	0,03 ml Dexamethasone Solu…	0,05 ml Dexamethasone Solu…
Endophthalmitis	Eye disorders	—	—	—
Retinal detachment	Eye disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	0,01ml Dexamethasone Solut…	0,03 ml Dexamethasone Solu…	0,05 ml Dexamethasone Solu…
Intraocular pressure elevation (IOP) > 5 mmHg from baseline	Eye disorders	—	—	—

Most-reported serious reactions: Endophthalmitis, Retinal detachment.

Data from ClinicalTrials.gov NCT03608839 adverse events section.

Sponsor's own description

Purpose: To determine the impact of short-term 4mg/ml dexamethasone solution treatment in diabetic macular edema (DME).

Design: Phase II, randomized, prospective, parallel, interventional study.

Participants: Pseudophakic patients with central-involved DME.

Methods: Twenty-seven patients with visual impairment caused by DME were randomized in a 1:1:1 ratio, in order to investigate treatment with 0.01 ml, 0.03 ml and 0.05 ml intravitreous dexamethasone solutions, and followed-up over 28 days

Outcome Measures: The primary outcome was macular thickness at three days after intravitreous dexamethasone. The secondary outcomes were macular thickness at 28 days after intravitreous dexamethasone, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) at three and 28 days after intravitreous dexamethasone

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of inflammation in immune system of diabetic retinopathy: Molecular mechanisms, pathogenetic role and therapeutic implications.
   Yue T, Shi Y, Luo S, Weng J, et al · · 2022 · cited 120× · PMID 36582230 · DOI 10.3389/fimmu.2022.1055087
2. Effect of intravitreal dexamethasone solution on the reduction of macular thickness in pseudophakic diabetic patients in a public hospital in Brazil: a randomized clinical trial.
   Fonseca ALA, Panetta H, Nascimento MA, Lira RPC, et al · · 2019 · cited 3× · PMID 31496644 · DOI 10.2147/opth.s214329